Erectile Dysfunction, Prostatism
Conditions
Keywords
Benign Prostatic Hypertrophy, Erectile Dysfunction, Nutritional Supplements, Prostatism, Lower Urinary Tract Symptoms, male
Brief summary
This is the first clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3, to investigate its effects on prostatism and erections, and its tolerability, when taken daily and twice-daily for 2 weeks.
Detailed description
This is a 2-week clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrullline, beta-sitosterol and vitamin D3, investigating its lower urinary tract effects, sexual effects, and tolerability in two dose regimens-daily for a week and twice daily for a week--in men who have Lower Urinary Tract Symptoms (LUTS) and may have erectile dysfunction (ED). No clinic visits are required. Subjects will be consented, screened, supplied with S4S, and tested via the Internet. Subset analyses will evaluate effects in three populations: men with at least moderate lower urinary tract symptoms (LUTS), according to standard score cutoff; men with at least moderate Erectile Dysfunction (ED, according to standard score cutoff; and all men dissatisfied with their urinary function and meeting minimal criteria for inclusion.
Interventions
DIETARY_SUPPLEMENTDr. Pyke's Supplement for Stream (S4S)
Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3
Sponsors
Robert E. Pyke
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized open-label crossover design with 1:1 allocation of first regimen as once daily or twice daily
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion requirements for all subjects 1. Men at least 40 years of age 2. Screening IPSS QoL must be 4-6: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Delighted (0), Pleased (1), Mostly Satisfied (2), Mixed (3), Mostly Dissatisfied (4), Unhappy (5), Terrible (6) 3. Gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations 4. Willing to buy S4S for $30, with the understanding that a rebate of $30 or a coupon for $30 off the cost of a second 30-dose supply of S4S will be offered if the subject completes the electronic questionnaires at the end of the treatment Required for target efficacy subset Meets criterion for at least moderate ED: IIEF-5 (erectile function) score \<13 - or: Meets criterion for at least moderate Lower urinary tract symptoms (LUTS): IPSS score at least 20
Exclusion criteria
1. Known allergy or sensitivity to ginseng, L-citrulline, canola oil or soybean oil. 2. Current severe side effects from any drug 3. Using medication(s) for angina pectoris, LUTS, or ED and has not consulted personal physician on advisability of participating in this study. 4. Women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety outcome: adverse events | 1 week | Reports from subjects of new or worse symptoms; number of patients with any adverse event, count and % of patients with each type of such adverse events |
| International Prostate Symptom Score (IPSS) | 1-4 weeks | measure of lower urinary tract symptoms in men with prostatism, total score; 0=best possible (no symptoms); 35 = worst possible; mean change and number of patients 50% improved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptoms Scale Quality of Life due to urinary symptoms | 1-4 weeks | categorical single-item self-report from delighted to terrible plus brief write-in; % improving by at least 1 point |
| International Index of Erectile Function (IIEF)-5 | 1-4 weeks | 5-item cluster on erectile function, score = 5 (worst possible) to 25 (completely normal); mean change and % improving by at least 2 points |
| Volunteer's Global Impression of Change in Erectile function | 1 week | categorical single-item self-report from very much improved to worse plus brief write-in; % improvement by at least 1 point |
| Secondary safety outcome: Adverse event dropouts | 1-2 weeks | Reports from subjects; number and % of patients |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events | 2 weeks | Rate of reported diagnoses from treating physicians if any subjects are hospitalized |
Outcome results
None listed